MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® INTERMITTENT FEMALE CATHETER; BARD UTIL-CATH VINYL FEMALE WHISTLE TIP INTERMITTENT CATHETER 14FR

Model Number	015914
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the catheters were sticky and could not be used.
Event or Problem Description
It was reported that the catheters were sticky and could not be used.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential failure mode could be ¿does not allow for easy insertion/removal of the catheter¿.A potential root cause for this failure could be "incorrect coating lumps or flakes".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿2.Holding the labia apart with one hand, take the catheter and insert the tip of the catheter slowly into the urethra.".

• Brand Name: BARD® INTERMITTENT FEMALE CATHETER
• Common Device Name: BARD UTIL-CATH VINYL FEMALE WHISTLE TIP INTERMITTENT CATHETER 14FR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9072526
• Report Number: 1018233-2019-05677
• Device Sequence Number: 3730712
• Product Code: KOD
• UDI-Device Identifier: 00801741039027
• UDI-Public: (01)00801741039027
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 015914
• Device Catalogue Number: 015914
• Device Lot Number: NGVL1435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 09/26/2019
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown